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An Efficacy and Safety Study of Cisapride in Patients With Chronic Gastroparesis After Failure of Other Treatment Options

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01281540
Recruitment Status : Terminated (Sponsor request)
First Posted : January 24, 2011
Last Update Posted : January 24, 2011
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Brief Summary:
The purpose of this study is to assess the effectiveness of cisapride in patients with a primary diagnosis of chronic gastroparesis (a stomach disorder) of unknown cause.

Condition or disease Intervention/treatment Phase
Gastroparesis Drug: Cisapride Drug: Placebo Phase 4

Detailed Description:
This is a double-blind (neither the physician nor the patient will know the name of assigned treatment) study to determine the effectiveness of cisapride tablets compared to placebo tablets (a tablet identical in appearance to cisapride but does not contain active drug) in patients with a primary diagnosis of idiopathic gastroparesis (a disorder of unknown cause in which the stomach empties its contents very slowly into the small intestine for digestion. Symptoms of gastroparesis may include vomiting, nausea, early feeling of fullness after only a few bites of food, weight loss due to poor absorption of nutrients or low calorie intake, abdominal bloating, poor glycemic (blood sugar) control, lack of appetite, and pain in the stomach area. Patients will take study drug (one 10-mg tablet of cisapride, or one tablet of placebo), orally, 4 times a day, for a period of 8 weeks. Study drug will be taken approximately 15 minutes before each meal, and, with a beverage, before going to bed.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-Blind, Randomized, Placebo-Controlled Trial To Assess Efficacy And Safety Of R051619 (Cisapride 10 mg q.i.d.) Versus Placebo For The Improvement Of Symptoms Associated With Exacerbations Of Idiopathic Gastroparesis, After Failure Of Other Treatment Options
Study Start Date : May 2003
Actual Study Completion Date : November 2003

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 001
Cisapride one 10 mg tablet 4 times a day for 8 weeks
Drug: Cisapride
one 10 mg tablet 4 times a day for 8 weeks

Placebo Comparator: 002
Placebo one placebo tablet 4 times a day for 8 weeks
Drug: Placebo
one placebo tablet 4 times a day for 8 weeks

Primary Outcome Measures :
  1. The average change from baseline in Gastroparesis Cardinal Symptoms Index (GCSI) score [ Time Frame: At baseline (Week 0) up to 8 weeks ]

Secondary Outcome Measures :
  1. The number and type of adverse events reported [ Time Frame: From time of first dose to the last dose (up to 8 weeks) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosed with nondiabetic idiopathic gastroparesis and having symptoms for at least 12 weeks in the preceeding 12 months
  • Experienced inadequate response, or intolerance to therapy to date
  • Have exacerbation of gastroparesis symptoms requiring medical attention
  • Demonstrate delayed gastric emptying as assessed by a [1-13C]-Sodium Acetate Breath Test within 14 days before randomization

Exclusion Criteria:

  • Received prior treatment with cisapride
  • Have a gycosylated hemoglobin (HbA1c) >7% and bloodglucose of 126 mg/dL (7.0 mmol/L) or greater at screening, as determined by clinical laboratory testing
  • Have any upper gastrointestinal (GI) pathology other than idiopathic gastroparesis that would require therapy other than that provided in this trial
  • Have any organic/neurological disease that is suspected to be causing gastroparesis
  • Currently vomiting, or receiving therapy for a severe exacerbation of gastroparesis, that would prevent the patient from receiving oral therapy or a diet

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01281540

Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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Responsible Party: Portfolio/CDT Leader, Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Identifier: NCT01281540    
Other Study ID Numbers: CR003949
First Posted: January 24, 2011    Key Record Dates
Last Update Posted: January 24, 2011
Last Verified: January 2011
Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Cisapride ( PREPULSID )
Stomach Diseases
Additional relevant MeSH terms:
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Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Neurologic Manifestations
Anti-Ulcer Agents
Gastrointestinal Agents
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs